IMPACCT: Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

摘要 两种常见上肢损伤--儿童内侧上髁骨折的处理 和移位的桡骨远端骨折(DRF)，是有争议的，具有较高的实用变异性。辩论在很大程度上 重点关注是减少这些损伤以恢复其正常位置，还是允许骨折在 他们受伤的位置，用简单的固定。观察性研究既支持简化，也支持简单 固定MEF和DRF。在这两种损伤中，很少有前瞻性研究，也没有随机研究。 评估他们的治疗情况。鉴于实践中的广泛差异，孩子们要么正在经历 当外科医生在麻醉/清醒状态下选择减量时，不必要的程序和麻醉事件 镇静或通过简单的固定治疗不足。这两种情况都是不能接受的，因为 要么面临麻醉风险和额外费用，要么面临潜在的长期功能障碍 为了解决这样的临床困境，肌肉骨骼儿科急救临床基础设施 组织了试验(IMPACCT)联盟，以开发必要的基础设施和经验 多中心随机临床试验。IMPACCT的领导力在领先的多中心临床试验方面拥有专业知识 它的成员代表了来自北美儿科骨科学会的32个不同的中心 (POSNA)。在防止核不扩散条约协商一致会议期间，与会者一致认为，多边基金和发展基金具有 均衡是必要的，也是最紧迫的临床争议。一项类似的优先级设定研究来自 英国认为这些问题是儿童骨科手术中的重要争议。 POSNA范围的调查证实了MEF和DRF治疗的差异以及外科医生愿意随机分组。 需要对患有MEF和DRF的儿童进行多中心随机优势试验来评估 麻醉/镇静下复位与单纯制动的临床疗效比较。中心假说 这项建议的好处是，在全身麻醉(MEF)或清醒镇静下进行还原治疗的儿童 (DRF)与简单固定治疗相比，患者报告的结果评分更高 独自一人。两种骨折的试验将同时进行，以利用规模经济和 在解剖位置、结果测量以及是否需要干预方面相似。三十岁- One Sites已经同意招募、随机和治疗总共688名患者，根据务实 协议。侦查员与审判创新网合作，提高审判效率 开发和执行。NIAMS已经授予这一倡议R34临床试验计划补助金。这 提案将支持当患者被招募、治疗和跟踪以及何时进行积极研究阶段 结果被分析和传播。 这些试验的完成将为今后提供一个框架、基础设施和经验 儿科骨科多中心前瞻性临床试验结果指导临床决策。

ABSTRACT The management of two common upper extremity injuries, pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF), is controversial with high practice variation. The debate largely focusses on whether to reduce these injuries to restore their usual position or to allow the fractures to heal in their injured position with simple immobilization. Observational studies support both reduction and simple immobilization for MEF and DRF. In both injuries, there have been few prospective and no randomized studies evaluating their treatment. Given the widespread variation in practice, children are either undergoing unnecessary procedures and anesthetic events when surgeons opt for reduction under anesthesia/ conscious sedation OR are being undertreated by simple immobilization. Both scenarios are unacceptable in that children face either anesthetic risks and extra costs or poor alignment with potential long term functional disability To address such clinical dilemmas, the Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) consortium was organized to develop the infrastructure and experience necessary for multicenter randomized clinical trials. IMPACCT’s leadership has expertise in leading multicenter clinical trials and its members represent 32 diverse centers from the Pediatric Orthopaedic Society of North America (POSNA). During the IMPACCT Consensus Conference, participants agreed that that MEF and DRF have the equipoise necessary and are the most pressing clinical controversies. A similar priority-setting study from the United Kingdom identified these questions as important controversies in children’s orthopaedic surgery. POSNA-wide surveys confirmed MEF and DRF treatment variation and surgeons’ willingness to randomize. A multicenter randomized superiority trial of children with MEF and DRF is required to evaluate the clinical effectiveness of reduction under anesthesia/sedation vs. simple immobilization. The central hypothesis of this proposal is that children treated with reduction under general anesthesia (MEF) or conscious sedation (DRF) will have higher patient reported outcome scores compared to those treated with simple immobilization alone. Trials on both fractures will be conducted simultaneously to take advantage of the economy of scale and are similar in terms of anatomic location, outcome measures, and whether an intervention is necessary. Thirty- one sites have agreed to recruit, randomize and treat a total of 688 patients according to the pragmatic protocols. Investigators have partnered with the Trial Innovation Network to increase the efficiency of trial development and execution. NIAMS has awarded this initiative an R34 Clinical Trials Planning Grant. This proposal will support the active study phase when patients are recruited, treated, and followed and when results are analyzed and disseminated. The completion of these trials will provide a framework, infrastructure and experience for future prospective multicenter clinical trials in pediatric orthopaedics as its results guide clinical decision-making.